CN103611074B - Preparation process of breast health soft capsule by directly filling part of uniformly mixed powder into capsule - Google Patents
Preparation process of breast health soft capsule by directly filling part of uniformly mixed powder into capsule Download PDFInfo
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Abstract
The invention discloses a preparation process of a breast health soft capsule by directly filling part of uniformly mixed powder into the capsule. A process line is designed for the soft capsule according to effective components and property thereof in medicines in a formula. By adopting vegetable oil as a dispersing medium and adding beewax and lecithin as suspending substances and passing a content through a colloid mill, then removing bubbles by an emulsifying machine and then pressing on a soft capsule machine, the effective substances enter the digestive tract in form of a liquid state, and can be quickly absorbed by the body, so that the bioavailability is improved, and the curative effect is enhanced. The breast health soft capsule is concerned by medical market and welcomed by patients with hyperplasia of mammary glands. Through the test of relative density of medicinal material fine powder, the test of relative density and viscosity of a matrix when the soft capsule is filled, the test on content uniformity of traditional Chinese medicinal material fine powder of the soft capsule, the content test of total alkaloids of thunberg fritillary bulb after a capsule fluid of the breast health soft capsule stands for 6-72 hours and the content test of total alkaloids of thunberg fritillary bulb in the soft capsule filling process, the preparation process is proved to be a production process with better stability.
Description
Technical field
The invention belongs to field of traditional Chinese, particularly relate to adopt that part crude drug mixes, the direct technique of fill soft capsule after sterilizing.
Background technology
Cyclomastopathy is that women is common, one of frequently-occurring disease, is more common in the 25-45 women in year, and the sickness rate of cyclomastopathy accounts for the first place of mastopathy.This disease sickness rate is rising year by year in recent years, and has the trend of the development of becoming younger.It is the disorder of the mammary gland normal configuration that causes of a kind of physiology hypertrophy and subinvolution in essence.In China, Cystic changes is rare, mainly with glandular hyperplasia, is main, therefore claim " cyclomastopathy ", belongs to pathological proliferation, it be neither inflammation a class of non-tumor is sick again.The World Health Organization's general designation " optimum mammary dysplasia ".The dangerous compared with normal women that primary disease cancerates increases 2-4 doubly, and clinical symptoms is sometimes mixed mutually with breast carcinoma with sign.Its main clinical characteristics is lump in breast and mastalgia.
Western medical treatment:
Main hormonotherapy and the incretotherapy (being main mainly with hormone medicine) of adopting, to estrogen antagonist, as oral methyl testosterone etc., corrects the unbalance of female, Progesterone Secretion, as Progesterone with androgen.Hormone receptor antagonists, as tamoxifen, thyroid hormones preparation, bromocriptine, red Na azoles, gonadal hormone etc., contestable ground and estrogen contention estrogen receptor, make estrogen cannot bring into play its biological effect.
Western medicine, although have certain effect, also have side effect significantly, and relapse rate is high simultaneously.Especially gonadal hormone, may further disturb the balance between the hormone of human body after application, and increases the possibility of canceration.Particularly primary disease needs Long-term taking medicine, and patient is difficult to adhere to, compliance is poor.So generally not using them as routine administration, only at serious symptom, when the normal work of impact and life, just consider to adopt.
The understanding of the traditional Chinese medical science, cyclomastopathy belongs to motherland's medical science " nodules of the breast " category, has another name called " newborn painful abdominal mass ", " nodule in the breast ", " newborn abdominal mass " etc.
The main opinion of < < surgeon great full ﹒ nodules of the breast door > > says: " nodules of the breast ... worry impairing spleen, anger brain injury stagnation of liver-QI knot forms also ";
< < Yangke Xinde Ji, Experience Gained in Treating External Diseases > > says: nodules of the breast is " nodule in the breast shape is as ball ovum; or distending pain or not bitterly, does not have a fever, and color of the leather is constant; the growth and decline with susceptible to anger of its core, this nodules of the breast ... ".
1, etiology and pathogenesis
1) feelings will not smooth → depression of liver-QI → qi depression to blood stasis → lump formation due to accumulation of pathogens
2) melancholy impairing the spleen → dysfunction of the spleen in transportation → accumulatively wet raise phlegm → cause expectorant is solidifying
3) newborn network → generation nodules of the breast is tied → blocked to gas, expectorant, the stasis of blood mutually
Chinese traditional treatment:
For stagnation of QI due to depression of the liver, expectorant stasis of blood cohesion pathogenesis,
The method of suiting measures to different conditions dispersing liver and promoting blood circulation, dissipating phlegm and resolving masses.
Breast caring soft capsule is comprised of 15 herbal medicines, Concha Ostreae hard masses softening and resolving, and Olibanum blood-activating and qi-promoting, two medicines phases 5, for the solidifying stagnation of QI and blood disease performance of the expectorant primary treatment effect of nodules of the breast, are monarch drug in square altogether; Fructus Trichosanthis, Sargassum resolving phlegm and softening hard masses, auxiliary Concha Ostreae strengthens the power of its hard masses softening and resolving, Myrrha, Rhizoma Sparganii helps Olibanum to increase the power of its blood circulation promoting and blood stasis dispelling, and four medicines are ministerial drug in the side of being altogether; Spica Prunellae mass dissipating and swelling eliminating, Bulbus Fritillariae Thunbergii powder detoxifcation, Rhizoma Curcumae removing blood stasis, Radix Salviae Miltiorrhizae nourishing blood and promoting blood circulation, Endothelium Corneum Gigeriae Galli relieving dyspepsia removing food stagnancy, above-mentioned five kinds of medicines assistant helps monarch-minister drug to strengthen the merit of dissipating phlegm and removing blood stasis; Radix Asparagi, Radix Scrophulariae YIN nourishing and the production of body fluid promoting, the product of assistant inhibition and generation expectorant removing blood stasis with potent drugs circulation of qi promoting, the fraud of hematozemia impairment of YIN, the Radix Astragali, Rhizoma Atractylodis Macrocephalae replenishing QI to invigorate the spleen, take into account the accompanied symptoms of nodules of the breast temper virtual loss, takes in the merit of strengthening vital QI to eliminate pathogenic factors concurrently, and above-mentioned nine herbal medicines are adjuvant in the side of being altogether.Take a broad view of full side, monarch reasonable compatibility, mainly for the main symptom of the nodules of the breast expectorant blood coagulation stasis of blood, take into account the stagnation of QI, insufficiency of the spleen accompanied symptoms, take again the blood-activating and qi-promoting that reduces phlegm into account, the fraud of all medicine impairment of YINs, make full side eliminating evil and just do not hinder, gather altogether the merit of removing blood stasis with potent drugs, regulating QI to relieve pain, air making-up and spleen enlivening of reducing phlegm, be suitable for nodules of the breast disease, the expectorant blood coagulation stasis of blood is main, has temper virtual loss disease concurrently.
1. to have content accurate for soft capsule dosage form, and craft science absorbs fast, active substance is wherein in vivo after disintegrate, after entering digestive tract with liquid form, can by health, be absorbed rapidly, the advantages such as bioavailability is high, rapid-action, good effect, and be more and more subject to market and patient's favor.
2. the course of processing of newborn caring soft capsule has adopted advanced lyophilization, micropowder technology, makes Chinese medicine cell wall breaking, and the rapid stripping of medicament effective component meeting, absorbs, and curative effect can double.
3. the attached Li Yan of the People's Hospital of Quanzhou, Fujian Province Medical college, associate chief physician published thesis in < < straits medical science > > the 2nd phase in 2009: " the routine clinical observation of newborn caring soft capsule associating tamoxifen treatment cystic cyclomastopathy 252 ".Object is observed the curative effect of tamoxifen breast caring soft capsule therapeutic alliance cystic cyclomastopathy.Method is divided A, B, C3 group by 252 routine cystic cyclomastopathy patients at random by the priority of emergency treatment.A organizes 82 examples, with tamoxifen, combines other Chinese patent drugs for treatment; B organizes 86 examples, with tamoxifen, adds newborn caring soft capsule treatment; C organizes 84 examples, treats separately with tamoxifen.Result A organizes total effective rate 78.05%, and B organizes total effective rate 95.35%, and C organizes total effective rate 66.67%, and B group is compared significant difference (P < 0.05) with A group, and B group is compared difference highly significant (P < 0.01) with C group.Conclusion breast caring soft capsule is combined use with tamoxifen, there is synergism, treatment cystic cyclomastopathy curative effect is obvious, effective percentage reaches 95.35%, while can obviously alleviate the toxic and side effects such as menoxenia due to tamoxifen Endocrine function effect, be the best drug combination for the treatment of cystic cyclomastopathy, potential applicability in clinical practice is wide.
Summary of the invention
This product is that tablet changes soft capsule into, adopts part crude drug powder to mix rear direct fill soft capsule, and makes it in pouring process, can keep the uniformity of crude drug powder, and be the major control link of this technical study.
The present invention is achieved in that
1. the mensuration of medical material fine powder relative density:
Determining instrument: MDMDY-2000 fully-automatic analyzer
Assay method: Endothelium Corneum Gigeriae Galli, Bulbus Fritillariae Thunbergii are ground into respectively to fine powder, Olibanum, Myrrha adopt low temperature process to be ground into fine powder, get three parts of fine powders, press the full-automatic Density Measuring Instrument rule of operation operation of MDMDY-2000, at 20 ℃ of true density of measuring medical material, compare with the density of 20 ℃ of water, the density result of relative density=medical material density/water of medical material.The average relative density of having measured three parts of medicated powder is 1.201.
2. relative density and the viscosity of substrate during soft capsule fill
The relative density determination of 2.1 substrate
According to appendix V II A relative density determination method Webster hydrometer method of Chinese Pharmacopoeia version in 2010, measure the relative density of 27 ℃ of substrate (containing medicated powder).The average relative density of having measured three parts of substrate is 1.068.
The dynamic viscosity of 2.2 substrate is measured
The temperature difference great disparity throughout the year in the north, larger to the dynamic viscosity of substrate and Effects of Density, therefore, we selected 0 ℃, 10 ℃, 15 ℃, 20 ℃, 25 ℃, 30 ℃, 35 ℃, 40 ℃ totally 8 groups carry out the viscosimetric analysis of substrate under different temperatures.Experimental result shows, 25 ℃ of dynamic viscosities of feed liquid when above meet soft capsule fill requirement.We select the temperature of 25～30 ℃ to carry out soft capsule fill, and its viscosity is 28000～35000mPas.
3. the content uniformity of newborn caring soft capsule Chinese crude drug fine powder is measured
Before 3.1 medicated powder mix with substrate, Bulbus Fritillariae Thunbergii total alkaloids in medicated powder is carried out to assay.
Get it filled at random 6 parts, powder, respectively takes 1.0g, and Bulbus Fritillariae Thunbergii total alkaloids is wherein carried out to assay.Average content (mg/g) is 0.3788; RSD% is 0.36.As can be seen from the above results, in medicated powder, total alkaloid content is even, illustrates that medicated powder mixing ratio is more even, can guarantee that soft capsule Chinese crude drug fine powder loading amount is even.
Before 3.2 soft capsule fills, the assay of the standing different time Bulbus Fritillariae Thunbergii of medicinal liquid total alkaloids.
Medicated powder is suspension through colloid mill after adding substrate vacuum emulsification again, and dispersibility is better, for guaranteeing that the loading amount of soft capsule Chinese crude drug fine powder is even after fill, we observe the standing 72h of medicinal liquid, the upper, middle and lower sampling of filling with from storage at 6h, 9h, 12h, 24h, 36h, 48h, 72h respectively, the content of mensuration Bulbus Fritillariae Thunbergii total alkaloids.From 72 hours 42 parts of measurement results, can find out, the content of Bulbus Fritillariae Thunbergii total alkaloids (mg/g) is between 0.146～0.156; RSD% is between 0.33～2.77.As can be seen from the above results, medicated powder mixes standing 72h with substrate, in tank, upper and lower Bulbus Fritillariae Thunbergii total alkaloid content difference is little, upper, middle and lower content is substantially even, even for guaranteeing soft capsule Chinese crude drug fine powder loading amount, we select the medicinal liquid preparing in 48h, to complete fill, in fact to fill in 72 hours, also do not affect Bulbus Fritillariae Thunbergii total alkaloid content.
In 3.3 newborn caring soft capsule pouring processes, the assay of Bulbus Fritillariae Thunbergii total alkaloids in different phase storage tank.
In order to control end product quality, we sampled respectively in the beginning, middle, end stage of pouring process, measured the content of Bulbus Fritillariae Thunbergii total alkaloids in soft capsule.In fill, start to sample 3 parts respectively; The average content of measuring Bulbus Fritillariae Thunbergii total alkaloids is 0.0753mg/ grain; In the middle of fill, sampling is 3 parts, and the average content of measuring Bulbus Fritillariae Thunbergii total alkaloids is 0.0752mg/ grain; 3 parts of the last samplings of fill, the average content of measuring Bulbus Fritillariae Thunbergii total alkaloids is 0.0752mg/ grain.The RSD% meansigma methods of three groups is 1.57.
From above result, find out each stage of fill, in newborn caring soft capsule, Bulbus Fritillariae Thunbergii total alkaloid content changes not quite, illustrates that medical material fine powder loading amount is wherein even.
4. the sedimentation velocity of medicated powder when fill
Medicated powder is suspension through colloid mill after adding substrate vacuum emulsification again, and dispersibility is better, and its sedimentation velocity is obeyed stokes law;
V-sedimentation velocity cm/s in formula;
R-particle radius cm;
ρ 1 and ρ 2-are respectively the density of microgranule and medium, g/ml;
G-acceleration of gravity cm/s2; (9.8m/s2=980cm/s2)
η-disperse medium viscosity g/ (cms);
4.1 particle radius～sieve method is measured
Get sieve No. six～nine, (R40/3 sieve series) sieve for Chinese Pharmacopoeia, by screen size order, be arranged above and below sieve is from coarse to fine, take the medicated powder 50gZhi the superiors, shake about 2min, weigh the medicated powder weight on each sieve, try to achieve different-grain diameter weight grading on each screen size, to obtain screening particle diameter.
The mean diameter d=95.53 μ m of medicated powder, so medicated powder radius is
r=d/2=47.765μm＝4.7765x10-3cm
4.2 density of particle see above face medical material fine powder relative density determination
4.3 density of matrix
According to appendix VII A relative density determination method Webster proportion of Chinese Pharmacopoeia version in 2000, claim method to measure the density of substrate (not containing medicated powder), the average density of substrate three duplicate samples is 0.8935.
The mensuration of 4.4 substrate viscosity
Viscosity is very large on the impact of fill, and by screening above, we are controlled at 27 ± 2 ℃ at the temperature during by fill, and at this temperature, we have surveyed the viscosity of substrate.The average viscosity of 3 duplicate samples is 353g/ (cms).
The calculating of 4.5 sedimentation velocity
Medical material fine powder sedimentation velocity is obeyed stokes law, brings above surveyed data into this formula calculated settlement speed.
From above-mentioned data, find out, true density and the density of matrix of medical material fine powder are more or less the same, and are added with suspending agent Cera Flava etc. in substrate, have improved the viscosity of substrate, and the increase of viscosity has reduced the sedimentation of fine powder, and the not layering at short notice of medical material fine powder and substrate is described; The standing 72h of medicinal liquid, in tank, upper and lower Bulbus Fritillariae Thunbergii total alkaloid content difference is less than 5%, and upper, middle and lower content is even; By measuring the sedimentation velocity of medical material fine powder, its sedimentation velocity is very little, does not affect the loading amount of soft capsule Chinese crude drug fine powder.While configuring medicinal liquid in actual production, medicinal liquid stirs by vacuum emulsion mixer, pass through again colloid mill, can make like this medicated powder and substrate fully mix, be suspension, and dispersibility is better, simultaneously the production capacity of soft capsule filling machine is 20,000 per hour, and every batch of medicinal liquid can complete fill in 24 hours, can sedimentation layering at pouring process Chinese crude drug fine powder, can make newborn caring soft capsule Chinese crude drug fine powder loading amount even, guarantee product quality.
In the density more than providing, viscosity, sedimentation velocity, newborn caring soft capsule, Bulbus Fritillariae Thunbergii total alkaloid content is the index of controlling soft capsule Chinese crude drug fine powder loading amount, in the large production of reality, can be used as internal control index.
Accompanying drawing explanation
Described in the embodiment of the present invention, soft capsule preparation process chart refers to Fig. 1.
Note: in Fig. 1, dash area is 300,000 grades of clean areas.
The specific embodiment
One, below in conjunction with specific embodiment, the invention will be further described, but not as limitation of the present invention.
Embodiment 1:
A newborn caring soft capsule preparation is to be made by the raw material of following percentage ratio:
Chinese medicine extract 8～18, crude drug powder 12～27, Cera Flava 1～4, lecithin 4～6, vegetable oil 48～72.
Embodiment 2:
A newborn caring soft capsule preparation is to be made by the raw material of following weight proportion:
Chinese medicine extract 8～18g, crude drug powder 12～27g, Cera Flava 1～4g, lecithin 4～6g, vegetable oil 48～72g.
Embodiment 3:
A newborn caring soft capsule preparation is to be made by the raw material of following weight proportion:
Chinese medicine extract 16g, crude drug powder 24g, Cera Flava 2g, soybean lecithin 5g, soybean salad oil 53g.
Two, newborn caring soft capsule toxicity test
Breast caring soft capsule is to acute toxicity test in mice
Test unit: Xi'an Jiaotong University Medical College's clinical pharmacology institute.
Test objective: observe animal occurs after newborn caring soft capsule gastric infusion acute toxic reaction and death condition.
Result of the test summary: in order to study the acute toxicity of newborn caring soft capsule, test is by mouse stomach administration, three times on the one, interval 4h, after the administration of 0.2ml/10g body weight there is slight perpendicular hair in mice, moving phenomenon reposes less, recover next day normal, have no other obvious poisoning symptoms, Continuous Observation 14 days, result has no dead mouse.Every day, mice largest cumulative dosage was 60ml/kg/ day (amounting to crude drug is 100.8g/kg/ day), was equivalent to 600 times of (people's consumptions: 0.05g/kg/ day) of Coming-of-Age Day consumption.Test shows that newborn caring soft capsule is without obvious acute toxicity.
Three, the newborn caring soft capsule test of pesticide effectiveness
The impact of breast caring soft capsule on guinea pig experimental cyclomastopathy
Test unit: Xi'an Jiaotong University Medical College's clinical pharmacology institute.
Test objective: observe newborn caring soft capsule and there is the effect of the cyclomastopathy of inhibition.This is tested animal model by experiment its main pharmacodynamics experiment is treated to observation, for clinical practice provides pharmacology foundation.
Result of the test summary: newborn caring soft capsule is the dosage changing form preparation of " RUKANG PIAN ", its composition of write out a prescription, function and curing mainly, usage level is all similar to RUKANG PIAN, is clinically mainly used in treating cyclomastopathy.For this reason, we have carried out newborn caring soft capsule to (estradiol+Progesterone), cause the experimentation of Cavia porcellus cyclomastopathy impact.Result of the test shows: newborn caring soft capsule to Cavia porcellus sex hormone level obviously reduce (E2P) and uterus, ovary, dirty body weight alleviates, pathological replacement explanation, heavy dose of group has obvious inhibitory action to cyclomastopathy.
Four, newborn caring soft capsule is approved as national 8 kind new medicines in December 9 Bei State Food and Drug Administrations in 2005.New Drug Certificate is numbered: traditional Chinese medicines card word Z20050818.New Drug Certificate holder is: Xi'an Bang Xin Medicines and Health Product Science and Technology Ltd..
Claims (1)
1. a newborn caring soft capsule preparation for the treatment of cyclomastopathy, it is characterized in that, this soft capsule content is mainly by Concha Ostreae 75g, Fructus Trichosanthis 75g, Sargassum 60g, Radix Astragali 120g, Radix Asparagi 60g, Spica Prunellae 75g, Rhizoma Sparganii 30g, Radix Scrophulariae 60g, Rhizoma Atractylodis Macrocephalae 60g, Rhizoma Curcumae 30g, Radix Salviae Miltiorrhizae 75g is extract and the Bulbus Fritillariae Thunbergii 30g of totally ten a herbs, Endothelium Corneum Gigeriae Galli 30g, Olibanum 30g, Myrrha 30g tetra-taste crude drug powder, and add vegetable oil, Cera Flava, after lecithin mixes, directly packing soft capsule into makes, each component percentages of this content is: Chinese medicine extract 16g, crude drug powder 24g, Cera Flava 2g, soybean lecithin 5g, soybean salad oil 53g,
Preparation technology:
(1) ten a herb material extraction process: Concha Ostreae, Fructus Trichosanthis, Sargassum, the Radix Astragali, Radix Asparagi, Spica Prunellae, Rhizoma Sparganii, Radix Scrophulariae, the Rhizoma Atractylodis Macrocephalae, Rhizoma Curcumae, Radix Salviae Miltiorrhizae are decocted with water to twice, decoct 1～3 hour at every turn, add 10～15 times of amounts of water; Collecting decoction, filters, and during concentrated filtrate to 60 ℃, recording relative density is 1.05, adds ethanol and makes to reach 70% containing alcohol amount, stir, and standing 24 hours, filter, after filtrate is concentrated, dry, pulverizing is that 100 order fine powders are standby;
(2) four taste crude drug powder preparations: Bulbus Fritillariae Thunbergii and Endothelium Corneum Gigeriae Galli are ground into respectively to fine powder, cross 100～150 mesh sieves standby; Olibanum, Myrrha pulverize at low temperature; Cross 100～150 mesh sieves, standby;
(3) Chinese medicine extract is fully mixed with crude drug powder, and add after vegetable oil, Cera Flava, lecithin vacuum emulsification, then be suspension through colloid mill, standby;
(4) with gelatin, glycerol, purification hydrated adhesive, standby;
(5) through pelleting, wash ball, the ball that dries in the air, select the techniques such as ball, plastic-aluminum to make newborn caring soft capsule.
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